Decision Makers and Influencers
Major Healthcare Stakeholders
Regulators and Policymakers
The US Department of Health and Human Services (HHS is responsible for protecting the health and providing essential human services for all Americans. Several agencies function under HHS, see below. HHS and state-level departments of health are responsible for developing and supervising the implementation of health policies, as well as managing a large part of healthcare expenditure via CMS. However, there is no strict target for federal- or state-wide healthcare expenditure.
Agency for Healthcare Research and Quality (AHRQ): The AHRQ’s mission is to produce evidence to make healthcare safer, of higher quality, more accessible, equitable, and affordable, and to work within HHS and with other partners to make sure that the evidence is understood and used.
Centers for Disease Control and Prevention (CDC): The CDC, part of the Public Health Service, protects the public health of the nation by providing leadership and direction for the prevention and control of diseases and other preventable conditions and responding to public health emergencies.
National Institutes of Health (NIH): The NIH, part of the Public Health Service, supports biomedical and behavioral research within the United States and abroad, conducts research in its own laboratories and clinics, trains promising young researchers, and promotes collecting and sharing medical knowledge.
Office of Inspector General (OIG): OIG protects the integrity of HHS programs as well as the health and welfare of the program participants.
The US Food and Drug Administration (FDA): The FDA, part of the Public Health Service, ensures that food is safe, pure, and wholesome; human and animal drugs, biological products, and medical devices are safe and effective; and electronic products that emit radiation are safe. In addition, FDA oversees regulatory approval of drugs, biologics, diagnostics, and devices in the United States.
Center for Drug Evaluation and Research (CDER): CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including generic drugs. This covers more than just pharmaceuticals. For example, fluoride toothpaste, antiperspirants, dandruff shampoos, and sunscreens are all considered "drugs."
Center for Biologics Evaluation and Research (CBER): CBER is the center within FDA that regulates biological products for human use under applicable federal laws. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
Center for Devices and Radiological Health (CDRH): CDRH ensures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the United States. The CDRH also oversees the Office of In Vitro Diagnostics and Radiological Health (OIR).
Payers
Centers for Medicare & Medicaid Services (CMS): CMS represents the public health insurance provider for around 30% of Americans and combines the oversight of the Medicare program, the federal portion of the Medicaid program and CHIP, the Health Insurance Marketplace, and related quality assurance activities.
Medicare: Medicare is a single-payer national health insurance program that began in 1966. Funding for this program comes from payroll taxes, premiums and surtaxes from beneficiaries, and general federal revenue. It primarily provides health insurance to Americans aged 65 and older who have paid into the Social Security system through payroll taxes. (for more information see The Facts on Medicare Spending and Financing under Suggested Reading) Additional health insurance coverage through Medicare is provided to younger people with some disability, patients with amyotrophic lateral sclerosis, or patients with renal failure requiring dialysis or transplant. Coverage for Medicare is broken down into 4 parts, A through D. Traditional Medicare plans (A, B, and D) do not contain an out-of-pocket spending limit.
Part A: Medicare Part A coverage relates to inpatient hospital costs, skilled nursing, and hospice services.
Part B: Medicare Part B coverage relates to outpatient physician services. Durable medical equipment (DME), such as diabetic testing supplies, is covered under these plans. Some drugs also may be covered under Medicare Part B and are usually treatments that require the intervention of a physician to administer, such as chemotherapy, immunosuppressant drugs, and dialysis drugs.
Part C: Also known as a Medicare Advantage (MA) Plan, Medicare Supplement Plans, or Medigap, Part C coverage is an alternative to traditional Medicare that allows patients to choose private plans with at least the same benefits of Parts A and B, and often D (as a Medicare Advantage Prescription Drug [MAPD] plan). These plans provide an annual out-of-pocket spending limit, which traditional Parts A and B plans do not contain.
Part D: Medicare Part D coverage relates to prescription drug coverage. This coverage has a standard benefit design for all patients. See Figure 5 below for a breakdown of costs for Medicare Part D plans in 2019. 21
Medicaid: Medicaid is a joint federal and state program that provides healthcare coverage for patients with limited income and resources. It is the largest source of funding for medical and health-related services for people with low income in the United States. It is jointly funded by the state and federal governments and managed by individual states, who determine eligibility. Recipients must be US citizens or legal permanent residents and may include low-income adults, their children, and people with certain disabilities. Poverty alone does not necessarily qualify a person for Medicaid.
State Children’s Health Insurance Program (CHIP): CHIP provides low-cost health coverage to children in families that earn too much to qualify for Medicaid. In some states, CHIP covers pregnant women as well. It is a jointly federal and state-funded program where individual states determine exact coverage rules; however, all states are required to provide basic comprehensive coverage including prescriptions and doctor visits. Routine visits are free under CHIP but there may be copayments for other services. Some states charge monthly premiums for CHIP coverage, but those will not be more than 5% of the family’s annual income. 22